CYCN

Cyclerion Appoints Regina Graul, Ph.D., as President

Retrieved on: 
Monday, December 4, 2023

CAMBRIDGE, Mass., Dec. 04, 2023 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), a biopharmaceutical company on a mission to develop treatments for serious diseases, today announced that Regina Graul, Ph.D., has joined the company as president, effective immediately. As Cyclerion’s president, she will lead the organization and will work closely with, and report directly to, the board of directors. She will be responsible for creating, implementing, and executing strategy as well as building a uniquely talented cross-functional management team.

Key Points: 
  • As Cyclerion’s president, she will lead the organization and will work closely with, and report directly to, the board of directors.
  • She will be responsible for creating, implementing, and executing strategy as well as building a uniquely talented cross-functional management team.
  • “Having worked with Regina personally for years at Microbia, Ironwood, and Cyclerion, I can attest to her effective leadership style, savvy sense of strategy, and ability to identify and advance promising science.
  • Previously, she served as olinciguat program lead at Cyclerion where she oversaw all aspects of olinciguat research and development.

Cyclerion Strengthens Board of Directors with Experienced Company Builder and Cutting-edge Innovator

Retrieved on: 
Thursday, November 30, 2023

CAMBRIDGE, Mass., Nov. 30, 2023 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), a biopharmaceutical company on a mission to develop treatments for serious diseases, today announced the appointments of Dina Katabi, Ph.D., and Michael Higgins to its Board of Directors.

Key Points: 
  • “Dina and Michael bring a unique combination of leadership capabilities, operating experience, and vast cutting-edge scientific knowledge.
  • Having a world-renowned innovator and a biopharma veteran join the board facilitates the transformation of Cyclerion as we look ahead to possible licenses, mergers, acquisitions and/or other targeted investments,” said Errol DeSouza, Ph.D., chairperson of Cyclerion Therapeutics.
  • She is the co-founder and president of Emerald Innovations, a health analytics company that specializes in digital health solutions for passive, contactless, in-home monitoring.
  • Mr. Higgins has been a long-time board member and board chair at other public and private companies.

Tisento Launches with $81 Million From Top-Tier Investor Syndicate and Promising Cyclerion Assets

Retrieved on: 
Monday, July 31, 2023

CAMBRIDGE, Mass., July 31, 2023 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (Nasdaq: CYCN) and Tisento Therapeutics, Inc. today announced the closing of the previously disclosed asset purchase agreement. Tisento is launching with an $81 million Series A financing to support its development of the Phase 2 soluble guanylate cyclase (sGC) stimulator zagociguat in MELAS and other genetic mitochondrial diseases, as well as the company’s advancement of additional assets for serious diseases with unmet need.

Key Points: 
  • Phase 2a clinical data, generated by Cyclerion, showed rapid improvements in disease-associated biomarkers in patients with MELAS who received zagociguat for 28 days.
  • Cyclerion received 10 percent equity ownership in Tisento with anti-dilution protection through $100 million in post-money valuation, as well as the right to purchase additional Tisento equity in the future.
  • The Tisento equity ownership provides Cyclerion shareholders with the opportunity to benefit from future Tisento value creation without further financial or operational obligations for the Tisento assets.
  • The launch of Tisento supports the optimal advancement of zagociguat and CY3018 while providing Cyclerion with near-term capital and potential future value for our shareholders.

Cyclerion Regains Compliance with Nasdaq Minimum Bid Price Requirement

Retrieved on: 
Thursday, June 1, 2023

CAMBRIDGE, Mass., June 01, 2023 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (“Cyclerion” or the “Company”) (Nasdaq: CYCN) today announced that it has received a formal notice from The Nasdaq Stock Market (Nasdaq) stating that Cyclerion has regained compliance with the $1.00 per share minimum bid price requirement pursuant to Nasdaq Listing Rule 5550(a)(2), and that Cyclerion is in compliance with all applicable listing standards.

Key Points: 
  • CAMBRIDGE, Mass., June 01, 2023 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (“Cyclerion” or the “Company”) (Nasdaq: CYCN) today announced that it has received a formal notice from The Nasdaq Stock Market (Nasdaq) stating that Cyclerion has regained compliance with the $1.00 per share minimum bid price requirement pursuant to Nasdaq Listing Rule 5550(a)(2), and that Cyclerion is in compliance with all applicable listing standards.
  • On June 1, 2022, Cyclerion was notified by Nasdaq that it was not in compliance with the minimum bid price rule because its common stock failed to meet the closing bid price of $1.00 or more for 30 consecutive business days.
  • In order to regain compliance with the Rule, the Company was required to maintain a minimum closing bid price of $1.00 or more for at least 10 consecutive trading days.
  • This requirement was met on May 30, 2023, the tenth consecutive trading day when the closing bid price of the Company's common stock was over $1.00.

Cyclerion Announces Reverse Stock Split

Retrieved on: 
Monday, May 15, 2023

CAMBRIDGE, Mass., May 15, 2023 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (the “Company”, “Cyclerion Therapeutics”, “Cyclerion”) (Nasdaq: CYCN) announced today that it will effect a reverse stock split of its outstanding shares of common stock at a ratio of 1-for-20, effective as of 5:00 p.m. Eastern Time on May 15, 2023.

Key Points: 
  • CAMBRIDGE, Mass., May 15, 2023 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (the “Company”, “Cyclerion Therapeutics”, “Cyclerion”) (Nasdaq: CYCN) announced today that it will effect a reverse stock split of its outstanding shares of common stock at a ratio of 1-for-20, effective as of 5:00 p.m. Eastern Time on May 15, 2023.
  • As a result of the reverse stock split, each twenty shares of the Company’s issued and outstanding common stock will be automatically combined and converted into one issued and outstanding share of common stock.
  • No fractional shares will be issued as a result of the reverse stock split.
  • Immediately after the reverse stock split becomes effective, there will be approximately 2,176,244 shares of common stock issued and outstanding.

Cyclerion Announces Corporate Updates and Q1 2023 Financial Results

Retrieved on: 
Thursday, May 11, 2023

Cyclerion CEO Peter Hecht Ph.D. to lead NewCo while continuing to serve on the Cyclerion board as one of the company’s largest shareholders

Key Points: 
  • Cyclerion CEO Peter Hecht Ph.D. to lead NewCo while continuing to serve on the Cyclerion board as one of the company’s largest shareholders
    Biopharma executive Errol De Souza Ph.D. elected as chair of the Cyclerion board
    CAMBRIDGE, Mass., May 11, 2023 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (Nasdaq: CYCN) today announced corporate updates and first quarter 2023 financial results.
  • Research and development expenses were approximately $3.8 million for Q1 2023, as compared to approximately $9.7 million for Q1 2022.
  • General and administrative expenses were approximately $3.3 million for Q1 2023, as compared to approximately $4.0 million for Q1 2022.
  • Net Loss: Net loss was approximately $7.0 million for Q1 2023, as compared to approximately $13.0 million for Q1 2022.

Cyclerion Announces Definitive Agreement for Zagociguat and CY3018

Retrieved on: 
Thursday, May 11, 2023

CAMBRIDGE, Mass., May 11, 2023 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (Nasdaq: CYCN) announced today that it has signed a definitive agreement with a new private company (“NewCo”) to sell two of its sGC stimulator assets in exchange for cash and equity ownership. Investors in NewCo have agreed to invest $81M to develop zagociguat (previously CY6463) to treat MELAS* and other diseases associated with mitochondrial dysfunction and advance CY3018.

Key Points: 
  • Investors in NewCo have agreed to invest $81M to develop zagociguat (previously CY6463) to treat MELAS* and other diseases associated with mitochondrial dysfunction and advance CY3018.
  • Each of the current Cyclerion investors who are participating in the NewCo capitalization have agreed to vote their Cyclerion shares in favor of the transaction.
  • Following the closing, NewCo will be solely responsible for all activities and expenses related to developing and commercializing zagociguat and CY3018.
  • Signing of the definitive agreement triggered the previously announced $5M equity investment by CEO Peter Hecht.

Cyclerion Therapeutics Enters into Exclusive Negotiation Period and Binding Equity Investment Agreement

Retrieved on: 
Monday, April 3, 2023

After consultation with its legal and financial advisors, the Independent Board has concluded that the proposal merits further pursuit.

Key Points: 
  • After consultation with its legal and financial advisors, the Independent Board has concluded that the proposal merits further pursuit.
  • Cyclerion has entered an exclusive negotiation arrangement for a limited period to allow the parties to negotiate binding documentation.
  • In addition, Cyclerion has entered into a binding agreement with CEO Peter Hecht for him to make an equity investment in Cyclerion of $5M in cash for common stock or nonvoting convertible preferred stock of Cyclerion, the purchase price, consistent with Nasdaq rules, to be at or above the market price at the time of signing that agreement.
  • The Company does not plan to provide further comment until an agreement is reached or the discussions are terminated.

Cyclerion Therapeutics Receives U.S. FDA Orphan Drug Designation for Zagociguat for the Treatment of Mitochondrial Diseases

Retrieved on: 
Monday, March 27, 2023

CAMBRIDGE, Mass., March 27, 2023 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), a clinical-stage biopharmaceutical company on a mission to develop treatments for serious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to zagociguat (previously CY6463) for the treatment of mitochondrial diseases.

Key Points: 
  • CAMBRIDGE, Mass., March 27, 2023 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. (Nasdaq: CYCN), a clinical-stage biopharmaceutical company on a mission to develop treatments for serious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to zagociguat (previously CY6463) for the treatment of mitochondrial diseases.
  • Zagociguat is the first CNS-penetrant sGC stimulator to be developed as a symptomatic and potentially disease-modifying therapy for serious diseases that involve the CNS.
  • “Orphan drug designation underscores the FDA’s recognition of zagociguat’s potential promise as a first-ever therapy for patients with MELAS, a rare, genetic mitochondrial disease,” said Peter Hecht, Ph.D., Chief Executive Officer of Cyclerion.
  • Orphan drug designation qualifies the sponsor of the drug for certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions, and seven-year marketing exclusivity upon FDA approval.

Cyclerion Reports Corporate Update and Full Year 2022 Financial Results

Retrieved on: 
Wednesday, March 22, 2023

More recently, Cyclerion filed a request with the FDA for Orphan Drug Designation and manufactured drug product to support the Phase 2b study.

Key Points: 
  • More recently, Cyclerion filed a request with the FDA for Orphan Drug Designation and manufactured drug product to support the Phase 2b study.
  • Cash, cash equivalents, and restricted cash balance on December 31, 2022 was approximately $13.4 million, as compared to approximately $20.4 million on September 30, 2022.
  • Research and development expenses were approximately $31.5 million for the full year 2022, as compared to approximately $37.6 million for the full year 2021.
  • Net Loss: Net loss was approximately $44.1 million for the full year 2022, as compared to $51.6 million for the full year 2021.